AiCuris Drug Letermovir (AIC246) Meets Primary Efficacy Endpoints in Phase 2 For Human Cytomegalovirus (HCMV) Prophylaxis

Trial shows a dose-dependent effect on the prevention of HCMV re-activation/re-infection and an excellent tolerability

16-Feb-2012 - Germany

AiCuris GmbH &Co KG announced positive results from its placebo-controlled and dose-ranging trial with Letermovir (AIC246). In addition to excellent efficacy Letermovir demonstrates superior tolerability and safety and thus defines a novel standard for the control of HCMV in transplant patients.

133 HCMV-seropositive allogeneic human blood precursor cell (HBPC) recipients were included in the trial. Given orally for 84 days, the two dosages of Letermovir, 120 mg and 240 mg once daily, meet both primary efficacy endpoints with high statistical significance vs. placebo. The efficacy endpoints are defined as incidence and time to onset of “HCMV prophylaxis failure”. Under Letermovir treatment such failure, defined as development of systemic detectable HCMV replication (viral load above assay cut-off of 42 DNA copies/ml) or HCMV End-Organ Disease, is suppressed.

In the primary Full Analysis Population, the incidence of failure due to efficacy failure of prophylaxis or due to discontinuation of treatment for any other reason prior to Day 84, is significantly lower in the Letermovir 240 mg/day (29.4%; p=0.007) and 120 mg/day (32.3%; p=0.014) groups compared to placebo (63.6%). The incidence of HCMV prophylaxis failure amongst patients receiving treatment for at least seven days prior to HCMV replication was none for Letermovir 240 mg (p=0.004 vs. placebo) and only 2 patients for Letermovir 120 mg (p=0.109 vs. placebo). Similarly, the time to onset of prophylaxis failure among patients receiving 240 mg/day of Letermovir was significantly different (p=0.02) compared to patients receiving placebo.

Letermovir, whatever the daily dosage, is safe and well tolerated. In addition, the analysis of safety demonstrates that - in all Letermovir groups combined - the percentage of patients with at least one treatment emergent adverse event (TEAE) either considered related to the treatment by the investigator, or leading to discontinuation of treatment (17.3% and 25.5%, respectively) is lower than in the placebo group (33.3% and 57.6%, respectively).

https://www.bionity.com/en/news/136513/aicuris-drug-letermovir-aic246-meets-primary-efficacy-endpoints-in-phase-2-for-human-cytomegalovirus-hcmv-prophylaxis.html